Dexamethasone with or without misoprostol to help start labor at term
Effect of Dexamethasone on Labour Induction in Term Pregnancies
This will test whether a dexamethasone shot, alone or with vaginal misoprostol, helps first-time women at term start active labor sooner.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Manial) |
| Trial ID | NCT07109258 on ClinicalTrials.gov |
What this trial studies
This randomized, controlled early phase 1 trial at Cairo University Hospital enrolls nulliparous women at or beyond 39 weeks with a singleton, vertex pregnancy who are eligible for induction. Participants are randomly assigned to one of three groups: a single intramuscular 8 mg dose of dexamethasone, vaginal misoprostol 25 μg every 6 hours (up to four doses), or dexamethasone given with the first misoprostol dose. The primary outcome is time from initiation of induction to the beginning of the active phase of labor, with secondary outcomes including duration of active labor, second stage length, mode of delivery, and fetal outcomes. Clinical assessment includes Bishop score, fetal biophysical profile, and inpatient monitoring during induction as per protocol.
Who should consider this trial
Good fit: Ideal candidates are first-time mothers over 18 with a singleton, vertex pregnancy at or after 39 weeks who have no contraindication to vaginal delivery.
Not a fit: Women with contraindications to vaginal delivery (such as prior cesarean, placenta previa, non-vertex presentation), preterm gestation, fetal macrosomia, or significant maternal medical disorders are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the intervention could shorten the time from induction to active labor and may reduce prolonged inductions or emergency cesarean deliveries.
How similar studies have performed: Vaginal misoprostol is an established induction method, but using dexamethasone alone or combined with misoprostol for induction is relatively novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years. * Nulliparous. * Vertex presentation. * Singleton pregnancy. * Gestational age ≥ 39 weeks according to a reliable date for the last menstrual period or a first-trimester ultrasound evaluation. * No contraindication for vaginal delivery. Exclusion Criteria: * Indication for cesarean section e. g. Placenta previa, intrauterine growth retardation, non-vertex presentation and previous cesarean section. * Maternal medical disorders as diabetes mellitus and severe pre-eclampsia. * Preterm labour and preterm rupture of membranes. * Gestational age \<39 weeks of gestation. * Fetal macrosomia \> 4kg (estimated by u/s).
Where this trial is running
Cairo, Manial
- Cairo University Hospital (Kasr Al Ainy) — Cairo, Manial, Egypt (Recruiting)
Study contacts
- Study coordinator: Abdelfatah M Eldesouky, MD, MRCOG
- Email: a.f.dessouki@gmail.com
- Phone: 00201003370784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.